A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:12/13/2018
Start Date:February 7, 2018
End Date:September 18, 2018

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A Multi-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Pharmacodynamics, Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Injection of ACT-246475 in Adults With Stable Coronary Artery Disease

The goal of this study is to find out if a drug called ACT-246475 can prevent platelets from
binding together when administered by an injection under the skin in the thigh or in the
belly. Another goal is to know how fast and for how long ACT-246475 works and if there is a
difference if the drug is injected in the thigh or in the belly. This study will also help to
find out more about the safety of this new drug.


Main Inclusion Criteria:

- 1. Signed informed consent prior to any study-mandated procedure.

- 2. Male and female subjects aged from 18-85 years, inclusive.

- 3. For women of childbearing potential: Negative urine pregnancy test at Visit 1 and
at Visit 2 before randomization.

- 4. Stable CAD defined by the presence of any of the following conditions:

1. History of CAD with coronary artery stenosis on coronary angiogram ≥50%.

2. Previously documented myocardial infarction occurring more than 3 months prior to
randomization.

- 5. Antiplatelet background therapy stable for at least 1 month prior to randomization.

- 6. Body weight ≥ 40.0 kg (88.2 lbs).

Main Exclusion Criteria:

- 1. Acute coronary syndrome, percutaneous coronary intervention or any intervention for
peripheral artery disease within 3 months prior to randomization.

- 2. Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to
randomization.

- 3. Active internal bleeding, or medical history of recent (< 1 month) bleeding
disorders or conditions associated with high risk of bleeding (e.g., clotting
disturbances, gastrointestinal bleed, hemoptysis).

- 4. Hemoglobin ≤ 10 g/dL at screening.

- 5. Loss of at least 250 mL of blood within 3 months of screening.

- 6. Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior
to screening (Visit 1).

- 7. Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand
disease).

- 8. Pregnant or breastfeeding women.
We found this trial at
8
sites
Falls Church, Virginia 22042
Phone: 703-776-7702
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Chicago, Illinois 73104
Phone: 847-663-8050
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1801 North Senate Avenue
Indianapolis, Indiana 46202
Phone: 317-962-0500
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Indianapolis, IN
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655 8th Street West
Jacksonville, Florida 32209
Phone: 904-244-4520
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Lutherville, Maryland 21093
Phone: 410-367-2591
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Lutherville, MD
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5000 Rue Bélanger
Montréal, Quebec H1T 1C8
Phone: 1 (514) 376 3330
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Montréal,
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New York, New York 10029
Phone: 212-241-7014
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New York, NY
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Tampa, Florida 33613
Phone: 813-615-7201
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Tampa, FL
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